Principal Product Quality Leader Job Washington area,District of Columbia USA,Quality Assurance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Product Quality Leader What you will do

Lets do this! Lets change the world! Amgens corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities.

Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

You will support one or more of Amgen's late-stage or commercial biologics products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems and product data management including comparability assessments, annual product reviews, and product quality risk assessments.

Your contributions will significantly improve initiatives intended to ensure the overall product health.

Primary Responsibilities include the following:

Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author PQ-owned regulatory filing sections and RTQs
Support science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

Additional Qualifications:

Functional

Skills:

Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Strong scientific data management and organization skills with attention to detail

Soft Skills:

Analytical and problem-solving skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation
Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
Team-oriented, with a focus on achieving team goals

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience OR
Masters degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
Bachelors degree and 6 years of Quality, Operations, Scientific, or Manufacturing experience OR
Associates degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience OR
High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications:

B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics,…